Kornimate/medical-research-clean huggingface dataset:
prostate biomarker study

Conditions: Prostate Cancer

Summary: radical prostatectomy (removal of the prostate) or radiation therapy provide excellent outcomes for patients with localized (confined to one area) disease, yet there is still no effective treatment once the disease has spread beyond the prostate gland. typically, a serum psa test is done to diagnose prostate cancer. following diagnosis, a prostate biopsy and other tests help to classify the patient's disease according to the likelihood of a recurrence. however, these assessments are imperfect. there is a need to identify and evaluate prostate biomarkers that will provide exact information regarding the likelihood of a recurrence (prediction) of prostate cancer.

the inter-spore prostate biomarkers study (ipbs) was established to prospectively collect and analyze biological specimens to predict and validate outcomes after treatment for prostate cancer. the study population will consist of patients scheduled to receive standard of care therapy for localized prostate cancer, either radical prostatectomy (rp) or radiation therapy (xrt; includes external beam radiation, brachytherapy, or both). seven hundred (700) patients (350 rp, 350 xrt) will be recruited from 11 spore sites over a two-year interval. we will collect serum, plasma, lymphocytes, and prostate tissue samples for distribution to collaborating biomarker validation sites at other prostate spores, along with clinical and epidemiologic data.

Eligibility criteria:
inclusion criteria: * males, 35 years of age or older, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland. * biopsy performed at the spore institution. * no prior therapy for prostate cancer (patients who receive neoadjuvant therapy after collection of blood and biopsy samples are eligible). * the patient should have 2 or more cores involved with carcinoma. the minimum amount of tumor submitted should be 5 mm, or at least 40% of the core involved with tumor. (this amount can be made up from 2 positive cores if 1 core is insufficient). * patients with clinical stage t1-t2a nxm0 prostate cancer who elect to be treated with rp or xrt (includes external beam radiation, brachytherapy, or both) at the spore institution. * patients with a nomogram predicted 5-year probability of freedom from biochemical recurrence (kattan 1998) of less than or equal to 85% (patients with intermediate risk of recurrence). * ability and willingness to sign informed consent exclusion criteria: * participation in a therapeutic clinical trial with an experimental agent. * previous cancer of any kind except non-melanoma skin cancer * previous surgical or minimally invasive treatment for enlarged prostate (e.g. turp, tuna, tuip, laser, microwave) * use of anti-androgen drugs during the 6 months prior to diagnosis * use of 5-alpha-reductase inhibitors during the 6 months prior to diagnosis

Keywords: prostate
a phase ii/iii study to evaluate the immunogenicity, safety and lot-to-lot consistency of lbvd, a fully liquid hexavalent diphtheria-tetanus-whole cell pertussis-hepatitis b-poliovirus-haemophilus influenzae type b conjugate (dtwp-hepb-ipv-hib) vaccine, in healthy infants as primary series

Conditions: Diphtheria; Tetanus; Pertussis; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type b

Summary: the purpose of this study is to evaluate immunogenicity, safety and lot-to-lot consistency of lbvd in comparison to co-administration of pentavalent vaccine and poliomyelitis vaccine (inactivated) in separate injections at four weeks after completion of three-dose primary series at 6-10-14 weeks of age when administered to healthy infants

stage 1 (phase 2) 1. to compare the immunogenicity and safety of lbvd to the licensed control vaccines at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age stage 2 (phase 3) 1. to demonstrate the non-inferior immunogenicity of lbvd to the licensed control vaccine at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age 2. to demonstrate lot-to-lot consistency in the immunogenicity of three separate lots of lbvd at 4 weeks after a three-dose primary series of vaccination given at 6-, 10- and 14-week of age

Eligibility criteria:
inclusion criteria: * healthy infants from 6 weeks to 8 weeks of age (both inclusive) * body weight ≥ 3.2 kg * born at full term pregnancy (≥ 37 weeks) * signed informed consent by parent(s) or legally acceptable representative(s) exclusion criteria: * known history of hib infection, hepb, diphtheria, tetanus, pertussis, or poliomyelitis * household contact or intimate exposure with a confirmed case of hib, hepb, diphtheria, pertussis, tetanus or poliomyelitis within 30 days prior to study registration * known history of sars-cov-2 infection * participant's mother is hepb antigen or hiv positive * fever ≥ 38.0 c/100.4 f within 3 days prior to enrollment * vaccination history of non-study vaccines within 30 days prior to enrollment except for pneumococcal conjugate, rotavirus, hepb and bacillus calmette guerin (bcg) * previous use of any diphtheria, tetanus, pertussis-based combination vaccine(s), hib conjugate, poliovirus, or combination * received immunosuppressive agents or other immune-modifying drugs * previous use of blood or blood-derived products * any history of allergy (hypersensitivity) to any of the vaccine components * participation in another interventional clinical trial within 4 weeks of expected first vaccination

Keywords: vaccination
atropine versus no atropine for neonatal rapid sequence intubation

Conditions: Bradycardia; Hypoxemia

Summary: the purpose of this study is to compare heart rate in infants who receive atropine as a part of their medication before intubation to those who do not. to be able to find out , we need to divided babies into 2 groups; group 1 : receives atropine + sedation + muscle relaxant group 2 : receives water or saline ( placebo group) + sedation + muscle relaxant then we need to compare heart rate during intubation and duration of intubation between the 2 groups.

we hypothesize that premedication for intubation with fentanyl and succinylcholine alone will maintain equal stability of heart rate and oxygen saturation without a prolongation of time to completion of intubation when compared to a protocol using atropine, fentanyl and succinylcholine. in order to answer this question we plan to undertake a prospective randomized double blinded control trial of use of atropine as an adjunct for elective intubation of infants less than 46 weeks postmenstrual age.

Eligibility criteria:
inclusion criteria: * any infant (preterm and term) up to 46 weeks corrected age requiring (nonemergent) intubation. * iv access is obtained * informed parental consent exclusion criteria: * emergent intubation or need for resuscitation * congenital cyanotic heart disease * obvious airway abnormalities * history of myopathy or family history of malignant hyperthermia or known history of phosphocholinesterase deficiency

Keywords: bradycardia hypoxemia intubation premedication
study of oral abbv-932 to assess adverse events and change in disease activity in adult participants with bipolar i or ii disorder

Conditions: Bipolar I Disorder; Bipolar II Disorder

Summary: bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population in the united states. this study will assess how safe and effective abbv-932 is in treating participants with bipolar i or ii disorder. abbv-932 is an investigational drug being developed for the treatment of depressive episodes in adult participants with bipolar i or ii disorder. study doctors put participants in 1 of 4 groups, called treatment arms. there is a 1 in 4 chance that a participant will be assigned to placebo. around 160 adult participants with bipolar i or ii disorder will be enrolled in approximately 40 sites worldwide. participants will receive oral capsules of abbv-932 or matching placebo once daily for 6 weeks. the treatment period will be followed by a safety follow-up (sfu) period for 4 weeks. there may be higher treatment burden for participants in this trial compared to their standard of care. participants will attend regular weekly visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual of mental disorders, fifth edition, text revision (dsm-5-tr) criteria for bipolar i or ii disorder without psychotic features based on the mini international neuropsychiatric interview (mini), with a current depressive episode of at least 4 weeks and not exceeding 12 months. * have a minimum score of 20 on the 17-item hamilton depression rating scale (hamd-17). * have a minimum score of 2 on item 1 of the hamd-17 at screening. exclusion criteria: * positive urine drug screen (uds) result at screening. * treated with any investigational drug within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug, is currently enrolled in another clinical study, or was previously enrolled in this study. * current use of any antipsychotic, antidepressant, anticonvulsant, mood stabilizer, herb, or over-the-counter medication with psychoactive potential within 1 week or 5 half-lives of the medication (whichever is longer). * prior exposure to abbv-932 within 90 days prior to baseline.

Keywords: bipolar i disorder bipolar ii disorder bipolar disorder abbv-932
dialysis of sugammadex in participants with severe renal impairment (study 19.4.333) (p05773)

Conditions: Neuromuscular Blockade

Summary: the clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.

the current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. a dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * american society of anesthesiologists (asa) class \>=4 * creatinine clearance (clcr) \< 30 ml/min and clinical indication for dialysis * hospitalization at intensive care unit (icu) and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium * scheduled for a (surgical) procedure in supine position * written informed consent (of the legal representative) exclusion criteria: * known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction * known or suspected to have a (family) history of malignant hyperthermia * known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia * have already participated in a sugammadex trial * have participated in another clinical trial, not preapproved by nv organon, within 30 days of study entry * females who are pregnant\* * females who are breast-feeding \* in females pregnancy will be excluded both from medical history and by a human chorionic gonadotropin (hcg) test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.
safety and efficacy study of botulinum toxin type a for the treatment of forehead and frown lines

Conditions: Facial Rhytides; Glabellar Frown Lines

Summary: this study evaluated the safety and efficacy of botulinum toxin type a compared to placebo for the treatment of forehead lines (facial rhytides) when also administered to frown lines (glabellar rhytides).


Eligibility criteria:
inclusion criteria: * moderate to severe forehead lines exclusion criteria: * current or previous botulinum toxin treatment of any serotype within one year * diagnosis of myasthenia gravis, eaton-lambert syndrome, amyotrophic lateral sclerosis * prior facial cosmetic surgery (e.g. prior periorbital surgery, facial lift, brow lift, eyelid lift or eyebrow surgery) * facial laser or light treatment, microdermabrasion, or superficial peels within 3 months * oral retinoid therapy within one year
silicone arthroplasty vs. arthrodesis in the distal interphalangeal joint

Conditions: Finger Joint; Arthroplasty; Replacement

Summary: the operational and favored standard therapy for the treatment of osteoarthritis in the distal interphalangeal joint is the arthrodesis, in which a titanium screw is used. arthrodesis shows in the most cases the complete reduction of osteoarthritis pain and low loss of function. but restrictions are reported in fine motor skills. the operation with silicone arthroplasty is similar. as an implant, a silicone joint is used, which has been sufficiently tested at the metacarpophalangeal joint and interphalangeal joint. the advantage of arthroplasty is the function obtained in the distal interphalangeal joint and the resulting improved fine motor skills.


Eligibility criteria:
inclusion criteria: * primary osteoarthritis in the distal interphalangeal joint * require surgical treatment * patient aged 18 years and over * signed written informed consent exclusion criteria: * posttraumatic osteoarthritis * rheumatoid disease * pregnant woman * any disease process that would preclude accurate evaluation (e.g. neuromuscular, psychiatric or metabolic disorder) * legal incompetence * no knowledge of german
comparing sedara to butorphanol in early labor

Conditions: Labor Pain

Summary: nitrous oxide (n2o) has been used for the treatment of labor pains for over 150 years. the longevity of its use in clinical practice can be attributed to its excellent safety profile, ease of administration, and familiarity of use among health-care providers. sedara is a self-administered 50% n2o, 50% oxygen gas mixture with pain relieving and anxiety reducing properties recently available for use in the united states (us) to treat various painful clnical situations, including labor pains. in the us, epidural or intravenous administration of narcotic medications is one of the most common and frequently requested treatments for patients experiencing labor pains. although generally considered safe, complications are common with epidurals, including fetal distress, low blood pressure in the mother, respiratory distress, and headache. in our hospital system, the use of the synthetic intravenous painkiller, butorphanol, is a mainstay of treatment for labor pains. it too can have undesirable side effects in the mother, including low blood pressure and breathing problems. because sedara has until recently been unavailable in the us, studies comparing its efficacy with other agents for labor pain have been confined to europe, predominantly in the united kingdom. several studies have investigated the efficacy of sedara versus inhalation and intravenous anesthetics in various countries. we have obtained several sedara devices for use in the west penn allegheny health system (wpahs) department of anesthesiology and would like to examine its efficacy in our target population of women experiencing pain during early labor. hypothesis - sedara will provide equivalent or superior pain relief among term, adult parturients in early labor (less than 5cm cervical dilation) compared to intravenous butorphanol. primary aim - compare sedara versus butorphanol in a single-blinded randomized trial with the main outcome measure being reduction in labor pains at various time intervals. our findings may be significant in terms of improving safety and efficacy of pain relief among women experienceing labor pains. given that sedara has not been previously studied in the us, the results may influence current obstetrical and pain management practices.


Eligibility criteria:
inclusion criteria: * female * 18 years of age or older * presents in active labor * full term pregnancy (at least 37 and up to 42 weeks gestation) * less than 5 cm cervical dilation on exam exclusion criteria: * patients who have received prior regional or opioid analgesia * patients who have taken oral analgesics (narcotic or non-steroidal anti inflammatory drugs) within 6 hours prior to presentation

Keywords: sedara nitrous oxide butorphanol visual analog scale
escitalopram treatment of major depression in patients with temporal lobe epilepsy

Conditions: Major Depression; Temporal Lobe Epilepsy

Summary: this is a research study evaluating the use of escitalopram (lexapro®) for the treatment of major depression in subjects with temporal lobe epilepsy. the purpose of the study is to measure the severity and change in depressive and anxiety symptoms after 10 weeks of study treatment with escitalopram or placebo as measured by certain rating scales and questionnaires. in addition, the study will measure the frequency of seizures using a patient diary during the study. finally, the study will assess the change in the quality of life using rating scales.


Eligibility criteria:
inclusion criteria: 1. subject has a confirmed diagnosis of temporal lobe epilepsy 2. subject meets dsm-iv criteria for major depression 3. madrs greater than or equal to 15 at screening and baseline 4. subject between ages of 18 and 65 5. female subjects of childbearing potential must take adequate contraceptive precautions (methods with a published failure rate of less than 1% per year, or condom/diaphragm, or diaphragm/spermicide) 6. subject must provide voluntary signed informed consent approved by the institutional review board of lsu health sciences center exclusion criteria: 1. any other primary axis i diagnosis other than major depression 2. the presence of psychogenic, non-epileptic seizures 3. a history of non-response to two or more antidepressants given for an adequate therapeutic trial 4. the presence of substance abuse or dependence in past six months 5. the presence of clinically significant malnutrition, cardiac, hepatic or renal disease that might endanger the safety of the subject 6. pregnancy or nursing 7. any subjects with suspected mental retardation, psychotic disorder or dementia 8. subjects whose anticonvulsant medication regimen includes phenobarbital 9. individuals who will require psychotropic medications such as benzodiazepines or medications likely to cause significant effects on mood or anxiety as outlined in section 5.4 10. cognitive-behavioral therapy will not be allowed during the course of the study. other psychotherapeutic modalities (supportive, psychoanalytic, etc.) will be allowed only if the individual has been in therapy for the previous 12 weeks and plans to remain in therapy throughout the duration of the study. 11. individuals who in the opinion of the investigator would not be able to understand or comply with study requirements 12. individuals with a known hypersensitivity to escitalopram or any of its ingredients 13. individuals who in the opinion of the investigator present a significant risk of suicide, or have had a significant suicide attempt in the past two years.
psychoeducation based on acceptance and commitment therapy

Conditions: Panic Disorder

Summary: the aim of this study is to manage individual psychoeducation in acceptance and commitment therapy for problems with panic disorder and to evaluate the effect of this program on rumination and self-resilience.

panic disorder; palpitations, sweating, tachycardia, fear of death, depersonalization, derealization, fear of going crazy, etc. it is a psychiatric disorder with symptoms. the most commonly used psychotherapy method for panic disorder patients is cognitive behavioral therapies. acceptance and commitment therapy is a psychotherapy method originating from cognitive behavioral therapy. acceptance and commitment therapy helps individuals act in the direction of their values by allowing them to contact their painful experiences rather than trying to escape or try to get rid of their difficult experiences, thoughts, and feelings. acceptance and commitment therapy supports psychological well-being by providing psychological flexibility in the person. rumination is mental rumination, which is used to keep thoughts spinning in the mind repetitively after an event.self-compassion is a concept used to mean understanding oneself despite one's mistakes. this study aims to create psychoeducation based on acceptance and commitment therapy for patients with panic disorder and to evaluate the effect of this program on rumination and self-compassion. psychoeducation, an evidence-based practice, is very important for the nursing profession. although nurses have a significant impact on psychoeducational practices, this role is ignored and not implemented adequately. in addition, since there is no research examining the concepts of rumination and self-compassion together in people with panic disorder, it is thought that our study will be useful in new research.

Eligibility criteria:
inclusion criteria: * patients diagnosed with panic disorder followed in muğla training and * research hospital psychiatry polyclinics, * those between the ages of 18-65 who agree to participate in the research, * those who were in a euthymic mood during the interview, according to physician control, * those who speak turkish, * those who are literate, * those who have a computer and internet access for the program to be conducted online if deemed necessary during the research process, * not having undergone such training within the last year is within the scope of the inclusion criteria. exclusion criteria: * having a diagnosis of a psychiatric disease in addition to panic disorder, * having an attack period during the training period, * individuals with cognitive (diagnosed by a physician) and physical disability (hearing, speaking, etc.) are included in the exclusion criteria from the study.

Keywords: rumination self-compassion